Trial Review

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1) To compare the clinical effectiveness of three alternative pharmacy-based Diabetes Screening interventions:a. Group A: screening based on AUSDRISK assessment tool alone with referral to a General Practitioner (GP) if AUSDRISK score greater than or equal to 12b. Group B: AUSDRISK assessment tool + HbA1c Point of Care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol) is detectedc. Group C: AUSDRISK assessment tool + capillary Blood Glucose Test Point of Care POC test in patients with AUSDRISKgreater than or equal to 12 followed by the referral to a GP if FBG greater than or equal to 5.5mmol/L or RBG greater than or equal to 7.0mmol/L is detected.The primary outcome is the difference in proportions of newly diagnosed Type 2 diabetes mellitus cases between the two interventions and the comparator arm, based on the subsequent GP assessment and blood test results. The secondary outcomes are the difference in proportions of newly diagnosed cases of pre-diabetes, the proportion who take up the referral to the GP; and the proportion of people referred to the GP.It is hypothesised that addition of either an HbA1c POC test or capillary Blood Glucose POC test to the AUSDRISK assessment alone is associated with a statistically significantly increase in the proportion of newly diagnosed Type 2 diabetes mellitus cases.2) To assessing the technical efficiency of alternative groups of pharmacy-delivered screening for T2DM.

The AUSDRISK 1 assessment tool is used to identify risk of developing type 2 diabetes. It asks the individual to report on a list of risk factors for type 2 diabetes. Each risk factors has a score. Some risk factors carry a high score (previous high blood glucose, age over 65 and waist measurement exceeding threshold) compared with other risks that carry a low score (eating fruit and vegetables every day). The score is additive and total score can range from 0 to 36. (1) Chen, L., D. J. Magliano, B. Balkau, S. Colagiuri, P. Z. Zimmet, A. M. Tonkin, P. Mitchell, P. J. Phillips and J. E. Shaw (2010). "AUSDRISK: an Australian Type 2 Diabetes Risk Assessment Tool based on demographic, lifestyle and simple anthropometric measures." Med J Aust 192(4): 197-202.

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Intervention code [1]2957990

Early detection / Screening

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Intervention code [2]2987880

Lifestyle

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Comparator / control treatment

In this trial the comparative arm is Group A where participants will receive pharmacy screening based on AUSDRISK assessment tool alone with referral to a GP if AUSDRISK score greater than or equal to 12.

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Control group

Active

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Outcomes

Primary outcome [1]2995000

Proportion of newly detected Type 2 diabetes and Prediabetes diagnosed on the basis of an OGTT or a fasting plasma glucose test, according to the criteria of the Australian Diabetes Association

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Timepoint [1]2995000

within 6 months post screening commencement

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Secondary outcome [1]3273510

% diagnosed with pre-diabetes - patient survey and GP records

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Timepoint [1]3273510

6 months post commencement of screening

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Secondary outcome [2]3274540

Proportion who have been referred to the GP - pharmacy records

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Timepoint [2]3274540

3 months post commencement of screening

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Secondary outcome [3]3274550

Proportion who take up the referral to the GP - patient survey and, GP records

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Timepoint [3]3274550

3 months post commencement of screening

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Eligibility

Key inclusion criteria

Adults between 35 and 75 years old;Living in the community (not a permanent resident of RACF ) or correction facilityWho do not have an established diagnosis of T2DM or pre-diabetes;or have not been screened in previous 12 months for T2DM/pre-diabetes using any of the tests included in the trial .To be eligible to participate in this 6CPA Pharmacy Trial Program a community pharmacy must:*be approved to dispense PBS medicines as part of the National Health Scheme defined in Section 90 of the National Health Act 1953 (Cth) (Section 90 pharmacy)*have an area of the community pharmacy that is physically separated from the retail trading floor so that the privacy and confidentiality of the patient is protected *appropriately store and dispose of reagents and consumables*obtain written patient consent in accordance with the Australian Privacy Principles (APP 3, APP 5, APP 6, APP 11 and APP 12)*be accredited by an approved Pharmacy Accreditation Program *adhere to the appropriate standards, terms and conditions, guidelines and protocols when providing the service*endeavours to include diabetes health check Continuing Professional Development (CPD) training in relevant pharmacists annual training plan as appropriate*agree to provide the data required for the evaluation of this trialPharmacists who take part in the trial will be required to undertake a CPD accredited online training course to enable consistent delivery of the interventions across the trial. The online training course will be accredited through an appropriate independent organisation.

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Minimum age

35Years

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Maximum age

75Years

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Gender

Both males and females

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Can healthy volunteers participate?

Yes

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Key exclusion criteria

Unable to give informed consent;Women who are pregnant;Based on patient self-report:Has an established diagnosis of T2DM or pre-diabetes;Has not been screened in previous 12 months for T2DM/pre-diabetes using any of the tests included in the trial Terminal illness;Has had a blood glucose test or OGTT for any other reasons associated with abnormal glucose homeostasis;

Clustered randomized controlled design - stratified sample of clusters by metropolitan/urban regional/rural,remote - random allocation to one of the 3 arms of the trial. All pharmacies in the cluster will implement the allocated service model for diabetes screening.

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Phase

Not Applicable

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

The primary outcome is the probability of newly diagnosed T2DM from all referred participants according to the results of the screening tools. The probability is estimated by the proportion of newly diagnosed T2DM with respect to the ITT population (defined as all patients who met the RCT selection criteria).Given the diverse demographic characteristics of participating pharmacies, we expect our sample to be similar in demographic characteristics to the Australian general population. Sample size calculations were based on a T2DM incidence of 4.6% distributed over the population age groups The baseline PPV of AUSDRISK (the comparator), was estimated to be 10% and the ratio of PPVs in the intervention vs the comparator is conservatively assumed to be 30% based on the published PPV of the AUSDRISK + capillary blood glucose reported The study needs to enrol 13,953 participants (4,651 in each group of the trial) in order to detect a 30% improvement on the ratio of PPVs of the screening methods (with AUSDRISK PPV as baseline), using a two-sided Cochran-Mantel-Haenszel (CMH) test conducted at the 5% significance level with 80% power, and making allowance for Type 2 diabetes (T2DM) incidence to range from 1.4% to 8.5% across the 4 age strata as shown in Table 7. Based on the distribution of clusters (pharmacies) according to the Australian metro/regional/rural population, an average of 85 participants per pharmacy was calculated. Given the trial is a cluster trial, there is potential for observations for individuals within the same cluster to be correlated (i.e., the outcomes for individuals within clusters are likely to be more similar than those across clusters). Given the lack of evidence for the true value of Intraclass Correlation Coefficient (ICC), the estimated ICC of 0.001. was chosen to be consistent (i.e. within the range) with a cluster-randomised controlled trial on screening for T2DM and population mortality and a systematic review summarising patterns of ICC from primary care research. The values of the average cluster size (85 participants per pharmacy) and the assumed ICC (0.001) produced a design effect of 1.1 needed to account for pharmacy clustering effect (i.e., an inflation factor applied to the assumed variance around parameter estimates, which is necessary to allow for correlations among patients included within clusters).

In conclusion, a total of 15,360 participants are required in the study (5,120 in each group of the trial). The sample size is further inflated to allow for attrition of up to 50%, therefore the total sample to be recruited is 30,720 participants (10,240 in each group of the trial).Since the alpha is spent on testing the null hypothesis associated with the primary objective that addition of either HbA1c Point of Care (POC) test or capillary blood glucose POC test to AUSDRISK assessment alone will be associated with a statistically significant increase in the proportion of new cases of T2DM in the intervention and the comparator armsStatistical AnalysisWe will adhere to ITT principles following CONSORT Statement guidelines. Baseline data will be secured prior to screening method allocation, missing values will be scrutinized to check for non-random distribution and analyses that utilize baseline data will be executed twice: once using observed data, and once using multiple imputation method. The Cochran-Mantel-Haenszel (CMH) test will be used to compare the differences in proportions of true T2DM detected between the screening methods. The CMH test takes account of the stratified randomisation and allows for variation between the strata in the underlying rates. The common odds ratio and its 95% confidence interval will also be reported as well as the results of the Breslow-Day test for homogeneity of the odds ratios across the strata. If there is significant heterogeneity in the odds ratios, the screening groups will also be compared, using Chi-squared tests, in separate subset analyses. In further supportive analyses, generalized linear mixed models (GLMMs) will be used to compare the probability of newly diagnosed T2DM after adjusting for clustering effect of pharmacy, baseline measurements and to explore possible interactions between baseline factors and screening methods.

THE UNIVERSITY OF SYDNEYLevel 2 Margaret Telfer Building (K07) The University of Sydney NSW 2006

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Ethics committee country [1]2958680

Australia

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Date submitted for ethics approval [1]2958680

06/07/2015

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Approval date [1]2958680

30/08/2016

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Ethics approval number [1]2958680

2016/637

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Summary

Brief summary

The objective of the Pharmacy Diabetes Screening trial funded under the Sixth Community Pharmacy Agreement (6CPA) Pharmacy Trial Program (PTP), and developed in partnership with the University of Sydney and Deakin University is to assess the comparative effectiveness and cost-effectiveness of alternative pharmacy-delivered models of opportunistic assessment for diabetes in an asymptomatic, previously undiagnosed population.The three groups to be compared include:Group A: screening based on Australian Diabetes Risk Assessment Tool (AUSDRISK) alone with referral to a GP if AUSDRISK greater than or equal to 12 Group B: AUSDRISK assessment tool + HbA1c point-of-care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol is detectedGroup C: AUSDRISK assessment tool + small capillary blood glucose test (scBGT) in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if fasting blood glucose (FBG) greater than or equal to 5.5mmol/L or random blood glucose (RBG)greater than or equal to 7.0mmol/L is detected.The primary outcome is the difference in proportions of newly diagnosed T2DM cases between the two interventions and the comparator arm to be identified by the subsequent GP assessment and blood tests results. The secondary outcomes to be assessed include: a) proportion of new diagnosed cases of pre-diabetes; b) proportion who take up the referral to the GP; and c) proportion of people referred to the GP.It is anticipated that this project will take approximately 20 months during which there will be approximately seven months of service provision.The primary economic objective of the study is to assess the technical efficiency of alternative models of pharmacy-delivered screening for T2DM. The broader objective of determining the value-for-money of pharmacy-delivered screening versus current practice (which does not involve pharmacy-delivered screening/referral), as would, for example, be required in a submission to MSAC requesting subsidy of pharmacy-delivered screening, is not addressed by the trial protocol. There is nonetheless an important value-for-money element to this trial. In the context of opportunistic screening to improve detection of T2DM, the population that visits GPs is different to the population that visits community pharmacies in one important aspect – people can just walk into pharmacies without an appointment, whereas this would be unusual for GPs. This difference in target populations potentially adds an allocative efficiency aspect to the ‘how to screen’ question.